Kornimate/medical-research-clean huggingface dataset:
microarray analysis of gene expression in liver tumors

Conditions: Liver Cancer

Summary: this study aims to study the gene expression profiles of liver tumors to help us understand their biology, and to find new tumor and treatment markers for liver cancer.

the purpose of this research is to study of the biologic features of liver tissue (by studying their gene expression profiles), so that we can increase our understanding of the processes involved in liver cancer development and growth. this may allow us to identify more effective ways of diagnosing, treating, and predicting the outcome of patients with liver cancer.

Eligibility criteria:
inclusion criteria:inclusion criteria: * patients with liver tumors undergoing partial liver resection, open liver biopsy, and patients undergoing liver transplantation with or without liver tumors at stanford university * patients older than 18
68ga-rm2 compared to 68ga-psma-617 pet/ct for intermediate risk prostate cancer imaging

Conditions: Prostate Cancer

Summary: patients with primary intermediate risk prostate cancer for whom radical prostatectomy is indicated, will be invited to participate to the present study. positron emission tomography coupled with scanner (pet-ct) using a radiotracer : 68ga-rm2 and positron emission tomography coupled with scanner (pet-ct) using another radiotracer : 68ga-psma-617, will be scheduled.

european association of urology (eau) guidelines for initial staging of intermediate risk prostate cancer (gleason score 3+4 and 4+3) include tomodensitometry (ct scan), magnetic resonance imaging (mri) and bone scintigraphy. however, this group of tumor is highly heterogeneous. a distinction exist between tumors with gleason score 3+4 (lower risk) and 4+3 which may be closer to high risk prostate cancer. consequently, management of these two sub-groups of tumors differs. the key point for optimal management of these tumors is to get specific and non-invasive molecular tools for better classification and stratification. this is of critical importance for personalized treatment decision-making. novel innovative radiotracers are today available for prostate cancer imaging notably small molecules, radiolabeled with 68ga, targeting the prostate specific membrane antigen (psma) or antagonists, radiolabeled with 68ga, targeting the gastrin-releasing peptide receptor (grp-r, a bombesin receptor subtype). there are on growing evidences that positron emission tomography coupled to computed tomography (pet-ct) with radiolabeled prostate specific membrane antigen analogues (psma) could be more sensitive and more specific for the detection of lymph node metastasis in high-risk cancers, as shown with psma-617 in recent studies.

Eligibility criteria:
inclusion criteria: 15 patients divided in : * 7 patients with favourable intermediate risk prostate cancer (ct2b or gleason score 7 (3+4) or psa value 10-20 ng/ml, briganti 5-20%,) * 8 patients with unfavourable intermediate risk prostate cancer (ct2b or gleason score 7 (4+3) or psa value 10-20 ng/ml, briganti 5-20%,) * who are candidate for radical prostatectomy after discussion in multidisciplinary committee * covered by the national health insurance system * with freely written informed consent obtained exclusion criteria: * any kind of previous treatment for prostate cancer (hormonal treatment, ebrt, brachytherapy, cryotherapy, etc...); * patient with prostate cancer not candidate for radical prostatectomy and/or unable to benefit from surgery * freedom privated patient * patient under legal protection or unable to express its own consent * known contraindication to radiopharmaceuticals and / or excipients ......

Keywords: prostate cancer 68ga-rm2 68ga-prostate specific membrane antigen pet/ct prostate cancer imaging
a study comparing pemetrexed plus cisplatin versus pemetrexed alone in nsclc patients who have progressed on first line egfr-tki

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: it has not been established whether platinum-based doublets is better than single agent chemotherapy in egfr mutant nsclc patients who failed first-line egfr tki. in this prospective trial, the investigators try to evaluate whether the progression-free survival of pemetrexed/cisplatin (pc) regimen is longer than that of pemetrexed single(p) regimen in nsclc patients who have progressed after first line treatment of egfr-tki.


Eligibility criteria:
inclusion criteria: * histologically confirmed nonsquamous nsclc with activating egfr mutation (on exon 19 deletion or exon 21 l858r mutation) * stage iiib, iv or recurrent nsclc (ajcc 7th criteria) * age ≥ 20 years * ecog performance status of 0 or 1 * at least one measurable lesion by recist 1.1 * progression after first line treatment with egfr tkis for advanced nsclc * asymptomatic brain metastasis or symptomatic brain metastasis treated with local treatment such as operation, whole brain radiotherapy, or gamma-knife surgery * at least 2 weeks later after whole brain radiotherapy or palliative radiotherapy * adequate renal function: estimated creatinine clearance ≥ 45 ml/min * organ function as evidenced by the following; absolute neutrophil count \> 1.5 x 109/l; platelets \> 100 x 109/l; total bilirubin ≤1.5 unl; ast and/or alt \< 3 unl, in case of known hepatic metastasis, ast/alt\< 5 unl * written informed consent form * no other previous systemic chemotherapy exclusion criteria: * uncontrolled systemic illness such as dm, chf, unstable angina, hypertension or arrhythmia * patients with post-obstructive pneumonia or uncontrolled serious infection * pregnant or nursing women (women of reproductive potential have to agree to use an effective contraceptive method) * uncontrolled symptomatic brain metastasis * presence of third space fluid which cannot be controlled by drainage * prior history of malignancy within 5 years from study entry except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer, well-treated thyroid cancer.

Keywords: failed in first line egfr-tki egfr activating mutation pemetrexed
services to enhance social functioning in adults with autism spectrum disorders

Conditions: Autism; Autism Spectrum Disorder; Autistic Disorder; Asperger Syndrome; Pervasive Developmental Disorder

Summary: the purpose of this study is to test a novel, three-part cognitive behavioral treatment strategy to improve social functioning in adults with autism spectrum disorder. the treatment, named tune in (training to understand and navigate emotions and interactions), includes components to address the many behavioral domains involved in social functioning, including social motivation, social anxiety, social cognition, social skills, and generalization of the skills to community settings. the investigators will test the efficacy of tune in to improve social functioning in adults with autism spectrum disorder (asd), using a randomized controlled trial using the srs-2 as the primary outcome measure.


Eligibility criteria:
inclusion criteria: * diagnosis of autism spectrum disorder exclusion criteria: * intellectual disability * severe mood or psychotic symptoms experienced in the past 4 weeks * severe self-injurious or aggressive behavior * severe extrapyramidal motor or sedating side effects of medications * concomitant participation in another social skills treatment program.

Keywords: autism autism spectrum disorder cognitive behavioral therapy
study to assess the influence of three different α-antagonists and placebo on the extent of weekly phenylephrine-induced mydriasis at three different concentrations of phenylephrine in healthy male volunteers

Conditions: Healthy

Summary: the study was aimed to evaluate the pharmacological effect of different α-antagonists on phenylephrine induced pupil size in healthy male volunteers as pharmacological basis for intraoperative floppy iris syndrome (ifis)


Eligibility criteria:
inclusion criteria: * healthy male * age ≥ 21 and ≤ 55 years * body mass index (bmi) ≥ 18.5 and ≤ 29.9 kg/m2 * signed and dated written informed consent in accordance with good clinical practice (gcp) and local legislation exclusion criteria: * any finding of the medical examination (including blood pressure, pulse rate and electrocardiogram (ecg)) deviating from normal and of clinical relevance * gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders * diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders * history of orthostatic hypotension, fainting spells or blackouts * chronic or relevant acute infections * history of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator * intake of drugs with a long half-life (\> 24:00 hours) within at least one month or less than ten half-lives of the respective drug before enrolment in the study or during the study * use of any drugs which might influence the results of the trial up to seven days prior to enrolment in the study or during the study * participation in another trial with an investigational drug (≤ two months prior to administration or during the trial) * smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day) * inability to refrain from smoking on in-house trial days * alcohol abuse (\> 60 g/day) * drug abuse * blood donation (≥ 100 ml within four weeks prior to administration or during the trial) * any laboratory value outside the clinically accepted reference range * excessive physical activities within the last week before the trial or during the trial the following exclusion criteria are of special interest for this study: * hypersensitivity to any alpha agonist, or to phenylephrine * supine blood pressure at screening of systolic \< 110 mmhg and diastolic \< 60 mmhg * ophthalmological criteria: * corrected visual acuity \< 0.5 * refractive error with a spherical equivalent \> +6 or smaller - 6 d * elevated intraocular pressure (higher than 22 mmhg) * relevant anisocoria or pupil deformation * history of eye surgery apart from laser trabeculoplasty less than three months previously or extraocular surgery such as strabismus surgery * topical ocular medication influencing iop (intraocular pressure) or pupil size within 3 months prior to study-start
improving detection and evidence-based care of nafld in latinx and black patients with type 2 diabetes

Conditions: NAFLD; Diabetes Mellitus

Summary: the primary objective of this pilot study is to assess the feasibility and acceptability of an intervention for improved detection and evidence-based care of nafld in latinx and black patients with type 2 diabetes (t2d) in duke university healthcare system (duhs). we will enroll 10-15 latinx and 10-15 black patients with t2d and nafld, based on having mildly elevated liver enzymes (alt \>/= 40 iu/ml in males, alt \>/= 31 iu/ml in females) and exclusion of other liver diseases (e.g., viral hepatitis, alcohol abuse). intervention content will include: 1) nafld education; 2)diet/lifestyle support; 3) t2d medication management; and 4) clinically-indicated liver testing and care. intervention feasibility will be evaluated by examining recruitment rates, retention rates, and study visit completion rates. acceptability will be assessed by survey and through qualitative interviews. the project objectives and intervention are minimal risk. the expected risks will not exceed those of usual care.


Eligibility criteria:
inclusion criteria: * people who identify as either: latino/latina/hispanic ethnicity and/or black or african american race * people with type 2 diabetes (t2d), as defined by icd-10 codes e11.xx. * patients with elevated serum alanine aminotransferase (alt) within duke university healthcare system (duhs). elevated alt will be defined as having at least two alt ≥40 iu/ml in males or ≥31 iu/ml in females in the preceding 12 months exclusion criteria: * people with hepatitis b or c infection * people with known alcohol overuse * people with current use of chemotherapy or other drugs known to affect liver function * people who have not been seen by a duhs primary care physician (pcp) or endocrinologist in the preceding year.
cystoscopy and cystodistension; therapeutic and aetiological aspect in overactive bladder

Conditions: Urinary Incontinence, Urge

Summary: this is an ethically approved randomised controlled study looking at whether cystodistension(filling the bladder with fluid under pressure) provides any benefit over cystoscopy alone (looking in the bladder) in women with refractory overactive bladder. urine samples will also be assessed for underlying infected cause of oab using urinalysis, microscopy and culture and cytokine assays (in collaboration with the university of kent). we hypothesize that cystodistension has a therapeutic benefit to women with refractory oab and the there is an increase prevalence in chronic urinary infections with raised cytokines in women with refractory oab.

we aim to measure outcomes initially, 6 weels and 6months follow-up. 1. resolution measured by urgency perception scale (ups). resolution of urgency will be assessed with the ups. the numbers of women with a level 3 ups score (hold and finish task) will be compared using chi square test in patients treated with cystodistension vs non cystodistension arms. 2. change in quality of life status determined by quality of life questionnaires will ismilarly be comapred between the 2 arms of the study. 3. change in urinary symptoms defined by patient's perception of intensity scale. change in uregncy scores will be compared between the 2 arms of the study. secondary outcome measure:1. prevalence of chronic urinary infection and organisms in patients with refractory oab 2. to identify whether urinary cytokines are present in a higher proportion of patients with oab. inclusion criteria 1. women with only oab symptoms 2. women who have failed bladder drill and anticholinergic agents 3. women who stopped medication due to side-effects or lack of efficacy 4. currently receiving no treatment exclusion criteria 1. patient with co-existing urodynamic stress incontinence 2. patients with neurological diseases 3. patients with pre-existing voiding dysfunction

Eligibility criteria:
inclusion criteria 1. women with only oab symptoms 2. women who have failed bladder drill and anticholinergic agents 3. women who stopped medication due to side-effects or lack of efficacy 4. currently receiving no treatment exclusion criteria 1. patients with co-existing urodynamic stress incontinence 2. patients with neurological diseases 3. patients with pre-existing voiding dysfunction * free flow rate \<5th centile or equivalent reduced pressure flow rate or * post-void residual volume greater than 100ml

Keywords: overactive bladder oab cystoscopy cystodistension uti cytokines
effect of bee-buzzy vibrating cold application and marionette doll on pain and fear during phlebotomy

Conditions: Fear of Pain

Summary: non-pharmacological methods are often used as a creative strategy to reduce pain and fear in children during a painful procedure such as phlebotomy. in this context, external vibratory cold application and a marionette doll are a commonly used as non-pharmacological distraction method to reduce pain and fear. in the literature, there are studies with cold application, vibrating devices and a marionette doll in bee appearance therefor this study is aimed to evaluate the effect of bee-buzzy vibrating cold application and marionette doll on pain and fear during phlebotomy among preschool children.

pain is one of the negative experiences faced in pediatric patients due to various medical interventions and often causes fear and anxiety. pain perception is affected by the child's age, cognitive development, communication skills, previous pain experiences, and pain beliefs. severe and long-term pain resulting from interventions can cause behavioral and physiological problems. in this period, if the pain is not alleviated or eliminated with appropriate interventions, it may cause neurological and behavioral disorders in the future. nurses are responsible for minimizing the pain felt by children exposed to painful interventions and helping them cope with it .

Eligibility criteria:
inclusion criteria: 1. children and parents who agreed to participate in the study 2. children had successful phlebotomy in the first attempt. exclusion criteria: 1. children who are having a chronic disease 2. mental disability or mental retardation 3. taking analgesics in the last 24 hours 4. undergone a surgical procedure, 5. not having a successful phlebotomy on the first attempt, 6. the child and his/her family not being willing to participate in the study.
pilot study on the flanks of asian patients

Conditions: Body Fat Disorder

Summary: this study will evaluate coolsculpting and the coolcurve applicator for non-invasive fat reduction in the flanks with sharp body curvature.

the purpose of this study is to evaluate the performance of the coolcurve+ applicator for non-invasive fat layer reduction in flanks for asian patient population.

Eligibility criteria:
inclusion criteria 1. male or female subjects \> 18 years of age. 2. subjects must be of asian descent. 3. subject has clearly visible fat on the flanks, which in the investigator's opinion, may benefit from the treatment. 4. subject has not had weight change exceeding 10 pounds in the preceding month. 5. subject with body mass index (bmi) up to 25. bmi is defined as weight in pounds multiplied by 703 divided by the square of the height in inches. 6. subject with sharp flank curvature that fits well with the coolcurve+ applicator. 7. subject agrees to maintain his/her weight (i.e., within 5 pounds) by not making any major changes in their diet or lifestyle during the course of the study. 8. subject has read and signed a written informed consent form. exclusion criteria 1. subject has had a surgical procedure(s) in the area of intended treatment. 2. subject has had an invasive fat reduction procedure (e.g., liposuction, abdominoplasty, mesotherapy) in the area of intended treatment. 3. subject has had a non-invasive fat reduction and/or body contouring procedure in the area of intended treatment within the past 6 months. 4. subject needs to administer, or has a known history of subcutaneous injections into the area of intended treatment (e.g., heparin, insulin) within the past month. 5. subject has a known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria. 6. subject has a known history of raynaud's disease, or any known condition with a response to cold exposure that limits blood flow to the skin. 7. subject has a history of bleeding disorder or is taking any medication that in the investigator's opinion may increase the subject's risk of bruising. 8. subject is taking or has taken diet pills or supplements for weight loss within the past month. 9. subject has any dermatological conditions, such as moderate to excessive skin laxity, or scars in the location of the treatment sites that may interfere with the treatment or evaluation (stretch marks is not an exclusion). 10. subject has an active implanted device such as a pacemaker, defibrillator, or drug delivery system 11. subject is pregnant or intending to become pregnant during the study period (in the next 4 months). 12. subject is lactating or has been lactating in the past 6 months. 13. subject is unable or unwilling to comply with the study requirements. 14. subject is currently enrolled in a clinical study of any other unapproved investigational drug or device. 15. any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject.

Keywords: lipolysis cryolipolysis fat reduction
pmcf neo pedicle screw and cage systems

Conditions: Degenerative Disc Disease; Spondylolisthesis; Spinal Stenosis; Spinal Tumor; Trauma; Pseudoarthrosis of Spine

Summary: the objectives of this clinical observational study is to evaluate the safety and efficacy (performance) of the neo pedicle screw system™ and the neo cage system™ interbody fusion device. to demonstrate non-inferiority of safety and function to an historical control from the published medical literature on competitive devices.


Eligibility criteria:
inclusion criteria: * patient has undergone or is intended to undergo surgery with the neo pedicle screw system™, standalone or in combination with the neo cage system™, for any of the approved indications as defined in the respective labelling * patient has participated in or is willing to participate in the routine postoperative follow-up program * patient is willing to provide written informed consent exclusion criteria: * patient is under the age of 18 or skeletally immature * patient had or has a contraindication to surgery or to any of the implant systems used in the study, as defined in the respective labelling
verification of risk assignment for whole chromosome using snp-based nipt in vanishing twin pregnancies

Conditions: Vanishing Twin; Trisomy 21; Trisomy 13; Trisomy 18

Summary: the purpose of this study is to collect blood samples from women carrying a vanishing twin pregnancy to further develop natera's non-invasive prenatal screening test to provide information about possible chromosomal conditions for the living twin


Eligibility criteria:
inclusion criteria: * women with either ultrasound-documented dizygotic (dz) twin pregnancy or those whose panorama test™ results suggest increased risk for vanishing twin exclusion criteria: * monozygotic twin pregnancy * non twin pregnancy * maternal history of bone marrow or organ transplantation